Exaprin Plus

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, minor arthritis pain, backache, common cold, menstrual cramps, and toothache. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 2 caplets with water every 6 hours as needed while symptoms persist. It is important not to exceed a total of 8 caplets within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

Warnings and Precautions

Children and teenagers should not use this medicine for chicken pox or flu symptoms without prior consultation with a healthcare professional regarding the risk of Reye’s syndrome, a rare but serious illness associated with aspirin use.

Allergy Alerts Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Similarly, acetaminophen may lead to severe skin reactions, including rash, blisters, or skin reddening.

Liver Warning This product contains acetaminophen, and severe liver damage may occur if the following conditions are met: concomitant use with other medications containing acetaminophen, exceeding 4,000 mg of acetaminophen within a 24-hour period, or consumption of three or more alcoholic drinks daily while using this product.

Stomach Bleeding Warning As this product contains a nonsteroidal anti-inflammatory drug (NSAID), there is a risk of severe stomach bleeding. The likelihood of this adverse effect increases in individuals who are 60 years or older, have a history of stomach ulcers or bleeding problems, exceed the recommended dosage or duration of use, take anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or use other medications containing NSAIDs (such as aspirin, ibuprofen, or naproxen).

General Precautions Healthcare professionals should advise patients to consult a doctor before use if they have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease, are taking diuretics, or have a history of stomach issues, including heartburn. Additionally, patients should seek guidance from a doctor or pharmacist if they are taking medications for diabetes, gout, or arthritis, are using any NSAID-containing drugs, or are uncertain whether their other medications contain acetaminophen.

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Discontinuation and Consultation Patients should stop using this product and contact a healthcare professional if any of the following occur: an allergic reaction, new symptoms, redness or swelling, ringing in the ears or hearing loss, worsening fever lasting more than three days, worsening pain lasting more than ten days, or any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

Serious Adverse Reactions Reye’s syndrome is a rare but serious illness associated with aspirin use, particularly in children and teenagers with chicken pox or flu symptoms. It is crucial that these patients consult a doctor before using this medicine. Additionally, aspirin may cause severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Acetaminophen, another component of this product, may lead to severe skin reactions, including rash, blisters, and skin reddening.

The product also carries a liver warning, as severe liver damage may occur if patients take it in conjunction with other drugs containing acetaminophen, exceed 4,000 mg of acetaminophen in a 24-hour period, or consume three or more alcoholic drinks daily while using this product. Furthermore, the presence of an NSAID in this formulation raises the risk of severe stomach bleeding, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking blood thinners, steroids, or other NSAIDs.

Common Adverse Reactions Patients are advised to stop use and seek medical attention if they experience any signs of an allergic reaction, new symptoms, redness or swelling, ringing in the ears, loss of hearing, worsening fever lasting more than three days, or pain that persists beyond ten days. Signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, also warrant immediate medical consultation.

Additional Considerations Patients should not use this product if they have a history of allergic reactions to any other pain reliever or fever reducer. It is also advised to avoid concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription. Prior to use, patients with asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease should consult a doctor. Additionally, those taking medications for diabetes, gout, or arthritis, or any other NSAIDs, should seek advice from a healthcare professional to ensure safety and avoid potential interactions.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Exaprin Plus (aspirin, acetaminophen, caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children and teenagers should not use this medicine for chickenpox or flu symptoms without consulting a doctor regarding the risk of Reye's syndrome, a rare but serious illness associated with aspirin use. For children under 12 years of age, it is advised to seek medical guidance before administration.

For adults and children aged 12 years and older, the recommended dosage is 2 caplets with water every 6 hours as needed while symptoms persist, with a maximum of 8 caplets in a 24-hour period unless otherwise directed by a healthcare professional.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an elevated risk for severe stomach bleeding. This increased risk necessitates careful consideration when prescribing medications that may exacerbate this condition.

Additionally, geriatric patients may experience a heightened susceptibility to stomach ulcers and bleeding complications. Therefore, it is crucial for healthcare providers to monitor these patients closely for any signs of gastrointestinal distress.

While no specific dosage adjustments are recommended for elderly patients, caution is advised due to their increased likelihood of experiencing adverse effects. Healthcare providers should remain vigilant in assessing the overall health status and medication tolerance of geriatric patients to ensure safe and effective treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, it may lead to adverse effects on the unborn child and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a healthcare provider, particularly in the later stages of pregnancy.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy or later unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if patients take this product in conjunction with other medications containing acetaminophen, exceed a total daily dose of 4,000 mg of acetaminophen, or consume three or more alcoholic drinks daily while using this product.

It is advised that patients with liver cirrhosis or other significant liver conditions consult a healthcare professional prior to use. Additionally, patients should be aware of the overdose warning associated with this product; taking more than the recommended dose may lead to liver damage. In the event of an overdose, prompt medical attention is critical for both adults and children, even if no signs or symptoms are immediately apparent. Patients are encouraged to seek medical help or contact a Poison Control Center at 1-800-222-1222 if an overdose is suspected.

Overdosage

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Prompt medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals are advised to take immediate action in cases of suspected overdose. It is imperative to seek medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222 for guidance and support in managing the situation effectively.

Timely intervention can mitigate potential complications associated with overdose, underscoring the importance of vigilance and prompt response in these scenarios.

Nonclinical Toxicology

It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of serious allergic reactions, including anaphylaxis, angioedema, and urticaria. Additionally, there have been reports of gastrointestinal bleeding, with some cases necessitating hospitalization. Cases of liver injury have been documented, particularly in patients who exceeded the recommended dose of acetaminophen or used it in conjunction with other acetaminophen-containing products. Furthermore, skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been associated with acetaminophen use. Other adverse reactions reported include tinnitus and hearing loss.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. It is important to counsel patients against using this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription.

Patients should be instructed to stop using the medication and seek medical attention immediately if they experience any signs of an allergic reaction. Additionally, they should be advised to discontinue use and consult a doctor if new symptoms arise, if there is any redness or swelling, or if they experience ringing in the ears or loss of hearing. Patients should also be informed to stop use and contact a healthcare professional if their fever worsens or persists for more than three days, or if their pain intensifies or lasts longer than ten days.

It is crucial to inform patients to seek medical advice if they notice any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve, as these may indicate a serious condition.

Patients should be encouraged to consult with their healthcare provider before using this medication if they have a history of asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease. They should also be advised to seek medical advice if they are taking a diuretic or have a history of stomach problems, such as heartburn, especially if the warning regarding stomach bleeding applies to them.

Furthermore, patients should be instructed to consult a doctor or pharmacist before using this medication if they are taking any drugs for diabetes, gout, or arthritis, or if they are using any medications that contain a nonsteroidal anti-inflammatory drug (NSAID). Lastly, patients should be encouraged to ask a healthcare professional if they are uncertain whether any other medications they are taking contain acetaminophen.

Storage and Handling

Caplets are supplied in sealed packets. It is imperative that the product not be used if the packet is torn, cut, or open. For optimal storage, maintain the product at a temperature range of 59° to 86°F (15° to 30°C). Additionally, it is essential to avoid exposure to excessive heat and humidity to ensure the integrity of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is particularly crucial to avoid the use of aspirin after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for Exaprin Plus, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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